Taxotere and Adriamycin/Cytoxan (AC) Validation in Breast Cancer Patients

NCT00206518 | Completed Phase 2 Results DMC

• 1 other identifier: H 16039
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn if the biomarker information obtained (learned or received) from the earlier studies can tell us whether or not Taxotere and/or Adriamycin/Cytoxan can cause tumors to become smaller.

Conditions

Breast Cancer

Keywords

Breast; Cancer; Taxotere; AC; Validation; Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)

  The patients' pathological response were assessed using Chevalier's system which graded the responses into Chevalier 1, 2, 3A, 3B, 3C, 3D, and 4, defined as: 1. Disappearance of all tumor either on macroscopic or microscopic assessment in both the breast and LN (pCR) 2. Presence of in situ carcinoma in the breast. No invasive tumor in breast and no tumor in LN (pCR) 3. Presence of invasive cancer with stromal alteration such as sclerosis or fibrosis (pPR) 3A: Subjectively \> 75% therapeutic effect 3B: Subjectively between 50% - 75% therapeutic effect 3C: Subjectively between 25% - 50% therapeutic effect 3D: Subjectively \< 25% therapeutic effect OR Grade 4 4. No or few modification of tumoral appearance (pNR).

  10 years

Secondary Outcomes (2)

• Disease Relapse

  10 years

• Overall Survival

  10 years

Study Arms (2)

A: Taxotere/Docetaxel

EXPERIMENTAL

Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.

Drug: Taxotere/Docetaxel; Drug: doxorubicin

B: AC Adriamycin/Cytoxan

EXPERIMENTAL

In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.

Drug: Adriamycin/Cytoxan

Interventions

Taxotere/Docetaxel DRUG

Taxotere

Also known as: docetaxel

A: Taxotere/Docetaxel

Adriamycin/Cytoxan DRUG

Adriamycin/Cytoxan

Also known as: doxorubicin

B: AC Adriamycin/Cytoxan

doxorubicin DRUG

AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.

Also known as: AC, ADRIAMYCIN/CYTOXAN

A: Taxotere/Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must be female.
• Signed informed consent.
• Primary breast cancers must be of clinical and/or radiologic size \>3 cm, and deemed surgically operable.
• Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential.
• Adequate bone marrow function:
• Hematocrit of greater than 30%,
• total neutrophil count must be \>1.5 x 10\^9/L and
• platelets of \> 100 x 10\^9/L prior to the start of any cycle.
• Renal function tests:
• creatinine within 1.5 times of the institution's upper limit of normal (ULN).
• Liver function tests:
• Total serum bilirubin within ULN, and
• liver transaminases within 2.5 times ULN, and
• alkaline phosphatase within 5 times ULN.
• Electrocardiogram showing no acute ischemic changes.

You may not qualify if:

• Patients with metastatic breast cancer.
• Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
• Women who are lactating or breastfeeding.
• Severe underlying chronic illness or disease.
• Peripheral neuropathy - grade 2 or greater.
• Patients on other investigational drugs while on study will be excluded.
• Severe or uncontrolled hypertension, history of congestive heart failure, acute myocardial infarction, or severe coronary arterial disease.
• Prior taxane or anthracycline chemotherapy for malignancy.
• Patients with a history of severe hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80.
• No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.

Sponsors & Collaborators

• Mothaffar Rimawi: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Baylor Breast Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Docetaxel; Doxorubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Tao Wang
• Organization: Baylor College of Medicine

taow@bcm.edu

7137985388

Study Officials

• Mothaffar Rimawi, MD

  Baylor Breast Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: September 1, 2004
• Primary Completion: October 1, 2016
• Study Completion: October 10, 2016
• Last Updated: July 28, 2020
• Results First Posted: June 6, 2017

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)